Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518356
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Mastoid TaVNS-fMRI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Direct Brain Effects of Activating the Auricular Branch of the Vagus Nerve from the Cymba Concha or Mastoid Process a Sham-controlled FMRI Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation taVNS will create different brain activation images Investigators will recruit 24 healthy participants The ear stimulation will be delivered while taking brain images using a magnetic resonance imaging MRI machine
Detailed Description:
Transcutaneous auricular vagus nerve stimulation taVNS is a non-invasive neuromodulation technique that delivers electric stimulation to the auricular branch of the vagus nerve ABVN This technique has been demonstrated effective in the treatment of depression and addiction in previous studies
Most previous applications of taVNS targeted the ABVN via the cymba conchae or tragus sites The mastoid process mastoid site is an important dermatome innervated by the ABVN but there is currently a lack of knowledge on how taVNS on the mastoid site affects brain activity and whether it differs from the effect of stimulating the cymba site
In this proposed study the investigators plan to explore whether delivering taVNS to the mastoid site and the cymba site can induce different patterns of brain activity Ultimately if successful this project will not only deepen our knowledge in basic neuroscience but also have great value in clinical applications since the mastoid site is a much more accessible ABVN target compared to other sites
Most previous applications of taVNS targeted the ABVN via the cymba conchae or tragus sites The mastoid process mastoid site is an important dermatome innervated by the ABVN but there is currently a lack of knowledge on how taVNS on the mastoid site affects brain activity and whether it differs from the effect of stimulating the cymba site
In this proposed study the investigators plan to explore whether delivering taVNS to the mastoid site and the cymba site can induce different patterns of brain activity Ultimately if successful this project will not only deepen our knowledge in basic neuroscience but also have great value in clinical applications since the mastoid site is a much more accessible ABVN target compared to other sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None